InceptivRecalls & reported problems across all models

We found 2 models of Inceptiv by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,852 adverse event reports in the FDA's MAUDE database, received between Jun 19, 2024 and Sep 30, 2026 — classified as 591 injuries, 1,261 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (315 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Inceptiv problems

Inceptiv models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Inceptiv™ 977119

  Stimulator, spinal-cord, totally implanted for pain relief
  1,339 reports
• Inceptiv™ 977119

  Stimulator, spinal-cord, totally implanted for pain relief
  513 reports

Recent Inceptiv adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Display or Visual Feedback Problem; Energy Output Problem; Electromagnetic Compatibility Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949575 ↗
• InjurySep 30, 2026Therapy Delivered to Incorrect Body Area

  Patient problems: Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 50948741 ↗
• InjurySep 30, 2026Energy Output Problem; Charging Problem; Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50948335 ↗
• MalfunctionSep 30, 2026High impedance

  Information was received from a manufacturer representative (rep) regarding a patient (pt) with an implantable neurostimulator (INS). Pt was being implanted with a new system. During the procedure impedances were tested. It was found that the 9 and 10 electrode were showing high impedances as well as a poor connection on the lead. Rep also reports troubleshooting performed by the surgeon as: The lead was pulled and cleaned twice. The port of the battery was suctioned out in case fluid made its way into the battery port. When tested again it showed the same high impedance/poor connection. For safety of the patient (the lead was anchored into place and the top tissue closed) it was decided by the surgeon to move forward. In the post op area, another impedance test was performed and it showed the 1,2,8,9,10 electrodes showing high impedances. We were able to program the patient successfully and get full coverage of her painful areas in the lower legs. No symptoms were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947515 ↗
• MalfunctionSep 30, 2026Migration or Expulsion of Device

  Information was received from a patient regarding an implantable neurostimulator. The reason for the call is pt states about they wanted to follow-up with a manufacturing representative (rep) regarding the MRI that was done about 1-1.5 months ago that showed "a couple of the leads have dropped". Agent reviewed rep role and redirected to the hcp. Agent sent email to the reps in the field. Additional information from the manufacturing representative (rep) indicated that the patient's hcp has been out, and they have not seen the patient. The rep indicated that they will work to schedule the patient for a reprogramming and try and reprogram based on the new lead position.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946847 ↗
• InjurySep 30, 2026Battery Problem

  Patient states the therapy has stopped working effectively and the battery is draining completely in two days.

  Patient problems: Insufficient Information

  MAUDE report 50946513 ↗
• MalfunctionSep 30, 2026Malposition of Device; Charging Problem

  Information was received from patient (pt) regarding an implantable neurostimulator (INS). It was reported that their INS was placed on a curve on their back and have troubles charging INS since they had it. Patient informed their healthcare provider (HCP) about it, but patient was not willing to have another surgery. Patient mentioned that they just have to be in a still position to get it to charge.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946026 ↗
• MalfunctionSep 29, 2026Use of Device Problem; Delayed Charge Time; Charging Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The reason for call was patient said that they couldn't charge INS, and it was taking a long time to charge INS and could be hard to find the right spot to charge. During the call they did long press on wireless recharger and then went into recharging application and tried to charge. They reported seeing the recovery mode screen. PT was going to continue in recovery mode and will then charge INS when they have time to do it and will call patient services back if they have any issues.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937340 ↗
• MalfunctionSep 29, 2026Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937202 ↗
• InjurySep 29, 2026Failure to Interrogate; Unstable; Communication or Transmission Problem; Patient Device Interaction Problem

  Patient problems: Discomfort; Insufficient Information; Swelling/ Edema

  MAUDE report 50936344 ↗
• MalfunctionSep 29, 2026Failure to Deliver Energy; Battery Problem; Communication or Transmission Problem; Electromagnetic Compatibility Problem

  Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (INS). The reason for call was rep reported that the patient (pt) had likely had a cardioversion yesterday because the patient was having heart issues and then the patient fell and was in the ICU today. manufacturer representative (rep) said the pt's implanted neurostimulator battery was not holding a charge. Rep said the tablet displayed message therapy off, contact your clinician: therapy is turned off, cannot provide the requested therapy, amplitude will be set to 0 in all active groups when trying to connect to INS. Rep tapped "set amplitudes to 0" and then got System error: 0X2CC6BEDE. During the call, the representative attempted to connect to the patient's Implanted Neurostimulator, but got a system error message. Rep reset stimulator 2 times and tried to connect to INS again, but got same amplitudes to 0 message followed by system error. Rep tried to connect to INS with pt programmer and got Service code 323. Rep said the only thing the pt could do is charge the INS. Technical Services (TSS) discussed likely cardioversion damage. No symptoms were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934477 ↗
• InjurySep 29, 2026Failure to Deliver Energy; Insufficient Device Problem Information

  Patient problems: Pain

  MAUDE report 50934245 ↗
• InjurySep 29, 2026Migration or Expulsion of Device; Unintended Collision

  Patient problems: Pain

  MAUDE report 50934227 ↗
• MalfunctionSep 29, 2026Failure to Interrogate; Communication or Transmission Problem; Electromagnetic Compatibility Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934224 ↗
• MalfunctionSep 29, 2026Battery Problem; Charging Problem

  Information was received from a patient (pt) regarding an implantable neurostimulator (INS). The pt reported that the newly implanted INS battery was not working well. They stated that the INS had been implanted in November and that they had needed to charge it frequently. Pt reported first noticing the issue about 3 months after implantation. They stated that the battery did not last more than 12 hours. Pt mentioned using SCS to avoid taking analgesic medication and expressed dissatisfaction with the device's battery performance. Agent reviewed INS battery duration. The pt was redirected to their healthcare provider (hcp) to further address the issue. Pt mentioned that they had contacted their HCP but had not yet received a response.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933874 ↗

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